MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED2-375-25

Device Problems Material Deformation (2976); Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2021

Event Type  malfunction  

Event Description

Medtronic received a report that there were deployment issues with the pipeline. The patient was undergoing surgery for treatment of a blister, unruptured aneurysm in the left middle cerebral artery near m2 segment with a max diameter of 1mm and a 1mm neck diameter. The landing zone was 3. 6mm on the distal side and 3. 8mm on the proximal side. It was noted the patient's vessel tortuosity was moderate. Angiographic result post procedure showed that flow rate in the aneurysm was reduced. It was reported that the device was parked distal to the aneurysm and attempt was made to deploy the device. Device failed to take wall opposition. Device was re sheath and another attempt was taken. In 2nd attempt resistance was observed in the catheter and device got kinked. There was catheter kickback/friction during delivery. The pipeline did not jump during deployment. The pipeline was not used for an indication that is not approved (off-label). The pipeline and any accessory devices were prepared as indicated in the ifu. It was reported that the microcatheter was placed near the aneurysm, device deployment was attempted. Device failed to open. In second attempt, resistance was observed and device got kinked in the distal section. The catheter was flushed as indicated in the ifu.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12961743
• MDR Text Key: 289194279
• Report Number: 2029214-2021-01580
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/06/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED2-375-25
• Device Catalogue Number: PED2-375-25
• Device Lot Number: B209934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial